Solana Company · NASDAQ:HSDT
Solana — Helius Medical Technologies — Investor Presentation (March 2019)
43 slides from Solana's investor presentation, Mar 20, 2019
Slide 1: A Revolution in Mind
A Revolution in Mind March 2019 184 60 36 238 116 33 109 110 114 146 161 153 Exhibit 99.1
Slide 2: Legal Disclaimers
Legal Disclaimers This presentation contains forward-looking statements, including statements about: uncertainties regarding the FDA regulatory approval process, including whether the results of our clinical trials will be sufficient to support an FDA approval of the PoNS™ device for marketing or wh
Slide 3: We are a neurotech company focused on neurological wellness
We are a neurotech company in the medical device industry focused on neurological wellness. www.heliusmedical.com | NASDAQ:HSDT | TSX:HSM
Slide 4: Management team
30+ years in the health sciences industry Former CEO at MediMedia Health Former President and CEO at GSW Worldwide (Division of inVentiv Health) Former Director of Neuroscience Marketing at Bristol-Myers Squibb Philippe Deschamps President, Chief Executive Officer & Chairman Dr. Jonathan Sackier Chi
Slide 5: Investment Highlights
Investment Highlights First in class, non-invasive neurotechnology with broad potential in treating symptoms of neurological disease and trauma Over 1.5M people in US with chronic balance deficit caused by Mild-to-Moderate Traumatic Brain Injury (mmTBI) “First mover advantage” with demonstrated safe
Slide 6: Large and Growing Addressable Market
People living with chronic balance deficit following an mmTBI in the U.S. alone3 Large and Growing Addressable Market People worldwide experience new TBI cases annually1 Chronic balance deficit is a long-term disability associated with neuro trauma and disease2 Gait speed, cadence, stride length and
Slide 7: Clinical Support for PoNS Treatment: RCT Enrollment Criteria
Clinical Support for PoNS™ Treatment: RCT Enrollment Criteria for Mild-to-Moderate TBI with Chronic Balance Deficit Safety and efficacy of PoNS Treatment demonstrated in two double-blind randomized controlled trials (RCTs) Enrollment criteria included patients with persisting balance deficit, despit
Slide 8: Significant, Sustained Improvement in Balance
In patients with mmTBI balance was significantly better at 2 Weeks, 14 Weeks and 26 Weeks Normal Range SOT Score N=221 12 weeks washout – no stimulation On average patients with mmTBI improved from an impaired SOT score to normal SOT score in 14 weeks of treatment with HFP. Normal SOT score was main
Slide 9: U.S. Regulatory Strategy
U.S. Regulatory Strategy US: De novo to 510(k) pathway Submitted for de novo classification and 510(k) clearance on August 2018 Received AI letter January 2019; submitted response March 2019 OUS: Canada: Health Canada clearance received 10/17/18 EU: Submitted CE Mark application 12/7/18 Australia: T
Slide 10: Commercializing PoNS Treatment in Canada (1/2)
US Reimbursement Strategy Focused on obtaining health economic data to facilitate reimbursement coverage Commercializing PoNS™ Treatment in Canada (Slide 1/2) Initial Focus on Canada: Clearance by Health Canada October 17, 2018 Over 350K people living with chronic balance deficit due to mmTBI Regula
Slide 11: Commercializing PoNS Treatment in Canada (2/2)
Deploy geographically targeted campaign to activate patients in proximity of certified PoNS™ neuroplasticity centers to inquire about PoNS™ Treatment Targeted patient segments at launch are cash pay and workers compensation Tactics include direct-to-patient digital campaign and partnership with pati
Slide 12: Planned Commercial Launch Summary PoNS Treatment in US
Build network of early adopter PoNS™ Tx centers Activate self pay and workers compensation patients Establish value proposition and treatment guidelines Planned Commercial Launch Summary PoNS™ Treatment in US Targeted promotion and scientific engagement to build advocacy, adoption, & experience Sign
Slide 13: Pre-Regulatory Clearance US Activities
Established Helius-sponsored Clinical Experience Programs (CEPs) Partnering with leading, early-adopter, neurorehabilitation centers: Partnerships in place with five neurorehabilitation centers (Northwell, OSU, OHSU, Kessler & Baylor) Patient recruitment and enrollment began in Q4’18 and continues i
Slide 14: Post-Clearance US Commercial Strategy
Commercialization of PoNS™ Treatment Post-Clearance US Commercial Strategy Build network of early adopter, high-volume PoNS™ Treatment centers Begin treating patients immediately following FDA clearance in Helius Neuro Rehab Center in Newtown, PA Convert CEP clinics into PoNS™ Treatment centers Depl
Slide 15: Raising Awareness of the PoNS Treatment
Raising Awareness of the PoNS™ Treatment Establishing Thought Leadership at Key Medical Meetings American Physiotherapy Association- January 23-26 Washington, DC KOL meetings / peer insight dinner North American Neuromodulation Society- January 17-20 Las Vegas, NV KOL meetings / peer insight dinner-
Slide 16: US Reimbursement Strategy
US Reimbursement Strategy Focused on obtaining health economic data to facilitate reimbursement coverage Reimbursement Strategy Multi-year effort to secure broad-based reimbursement coverage: Focused on accumulating health economic data to support pursuit of coverage and payment Near-term priority:
Slide 17: Additional Clinical Progress and Potential Opportunities
PoNS™ Additional Clinical Progress and Potential Opportunities Multiple Sclerosis (1M People) Parkinson’s Disease (1M People; 60K new each year) Stroke (7M People; 795K new each year) Facial Nerve Palsy (75K People) Depression (15.7M People) PTSD (25M People) Cerebral Palsy (764K People) Indication
Slide 18: Financial Overview
Financial Overview $25.6M cash and no outstanding debt as of December 31, 2018 November 2018: Completed registered public offering with net proceeds of $18.3M at price of $8.25, led by BTIG and Oppenheimer Full Year 2018 Summary: Reported First Company Revenue: $0.5M, licensing fee for Canadian righ
Slide 19: Full Year 2019 Outlook
Full Year 2019 Outlook www.heliusmedical.com | NASDAQ:HSDT | TSX:HSM 2019 Guidance: For 2019, we expect total revenue in a range of $1.6 million to $2.0 million U.S. dollars. Assumptions Supporting 2019 Guidance: 2019 revenue guidance assumes an exchange rate of $1 Canadian dollar to $0.75 US dollar
Slide 20: Extensive IP Portfolio
Extensive IP Portfolio A Significant Barrier to Competitor Entry Exclusively licensed from inventors (4% royalty): 8 US Medical Method Patents Issued Patents expire 2028 Patents owned by Helius (no royalty): 27 US Patents Issued 20 Foreign Patents Issued Patents expire 2035 Helius Patents Transferre
Slide 21: References
References Slide 6: Traumatic Brain Injury *Maas et. Al. (2017). Traumatic brain injury: integrated approaches to improve prevention, clinical care, and research. The Lancet Neurology. 16. 10.1016/S1474-4422(17)30371-X. https://www.researchgate.net/publication/320898726_Traumatic_brain_injury_integr
Slide 22: References
References Slide 17: Disease State Prevalence Multiple Sclerosis - http://www.nationalmssociety.org/About-the-Society/MS-Prevalence Cerebral Palsy: http://www.cerebralpalsy.org/about-cerebral-palsy/prevalence-and-incidence Stroke – http://www.strokeassociation.org/STROKEORG/LifeAfterStroke/Life-Afte
Slide 23: Helius Medical Technologies contact details
184 60 36 238 116 33 109 110 114 146 161 153 Helius Medical Technologies, Inc. │642 Newtown Yardley Road, Suite 100 │ Newtown, PA 18940 215 944-6100 │ info@heliusmedical.com │ www.heliusmedical.com
Slide 24: Tongue Based Neuromodulation
Tongue Based Neuromodulation The PoNS® investigational medical device gently stimulates the trigeminal nerve through the tongue to activate neuroplasticity in the brain and unlock its ability to restore lost function. Tongue Based Neuromodulation The nerves in the tongue are directly connected to th
Slide 25: A Smart Device
The PoNS device is a smart technology that tracks frequency, duration and intensity of use Data captured is uploaded to cloud to be analyzed to drive PT and HCP treatment decisions and provide details on compliance for payer reimbursement opportunities Why PoNS? A Smart Device One Smart Device www.h
Slide 26: PoNS Registrational Trial in TBI
PoNS® Registrational Trial in TBI Important Criteria For the Study 120 subjects Response criteria was set at 15 point improvement in Sensory Organization Test (SOT), an objective measure used in balance research 15 point SOT score improvement is 50% higher than the expectation in the medical literat
Slide 27: Pre-Treatment Video
Pre-Treatment Video www.heliusmedical.com | TSX:HSM | NASDAQ:HSDT Pre-Treatment Video
Slide 28: Post-Treatment
Post-Treatment Quetius
Slide 29: Investor Contact
Investor Contact: Mike Piccinino, CFA 443-213-0500 info@heliusmedical.com Helius Medical Technologies, Inc. │642 Newtown Yardley Road, Suite 100 │Newtown, PA 18940 T: 215 944-6100 │E: info@heliusmedical.com │W: www.heliusmedical.com 184 60 36 238 116 33 109 110 114 146 161 153
Slide 30: References
References Slide 6 Traumatic Brain Injury *Maas et. Al. (2017). Traumatic brain injury: integrated approaches to improve prevention, clinical care, and research. The Lancet Neurology. 16. 10.1016/S1474-4422(17)30371-X. https://www.researchgate.net/publication/320898726_Traumatic_brain_injury_integra
Slide 31: References
References Slide 22: Scientific Evidence 1. Shiflett JM, Parent AD, Britz GW, Golanov EV. Forehead stimulation decreases volume of the infarction triggered by permanent occlusion of middle cerebral artery in rats. J Neurol Stroke. 2015;2(5):00067 2. Chiluwal A, Narayan RK, Chaung W, et al.Neuroprote
Slide 32: Other Science
Other Science Quetius
Slide 33: Scientific Basis that Trigeminal Nerve Stimulation Impacts Brain Physiology
Scientific Basis that Trigeminal Nerve Stimulation Positively Impacts Brain Physiology Nature Scientific Reports, Chiluwal A., Narayan R., Chung W. et al. 20172 Rat model of TBI Improved blood flow Smaller lesion Better blood brain barrier Less edema Lower pro-inflammatory markers Journal of Neurolo
Slide 34: Independent EEG study
In an independent EEG study, stimulation showed increased activity above baseline during and after stimulation for the attention microstate % change Baseline Post-Stimulation Stimulation n= 20 neurologically intact volunteers Data on file, Helius Medical 2017 Time
Slide 35: Results from Multiple Sclerosis Study
Results from Multiple Sclerosis Study fMRI Changes in Group A, B vs Healthy Controls 14 subject (7/7) study: All received physiotherapy with Group A receiving HFP PoNS® stimulation and Group B non-perceivable stimulation PoNS® VOIs bold signal vs. Healthy controls Right DLPFC Left DLPFC** * rACC***
Slide 36: Sensory Organization Test – Standard Clinical Endpoint for Balance
Sensory Organization Test (SOT) – Standard Clinical Endpoint for Balance Scale: Degree of sway Sensory Organization Test Computerized posturography using 6 conditions to interpret a person’s degree of sway Unable to stand unaided People with TBI-induced balance issues PT alone improves SOT by 8-10 p
Slide 37: PoNS Registrational Trial in TBI Clinical Study
PoNS® Registrational Trial in TBI Clinical Study A double-blind, randomized, controlled* study of the safety and effectiveness of the PoNS® device for translingual noninvasive neuromodulation stimulation (“TLNS”) training in subjects with a chronic balance deficit due to mild to moderate (mTBI) Indi
Slide 38: PoNS Registrational Trial in TBI (con't)
PoNS® Registrational Trial in TBI (con’t) Important Criteria For the Study All subjects were at least one year post-injury Further spontaneous recovery unlikely All subjects had to: Have participated in a focused physical rehabilitation program and have reached a plateau Still have significant balan
Slide 39: PoNS Responder Analysis
PoNS® Responder Analysis p<0.0005 vs Baseline N=122 Percent Responders High Frequency Pulse And Low Frequency Pulse Stimulation Combined
Slide 40: PoNS Study Efficacy - Time Course Data
PoNS® Study Efficacy - Time Course Data ∆ 20.3 ∆ 27.6 Normal Range SOT Score N=613 HFP Neuro-Stimulation + PT 1HFP: Mean increase over baseline at end of Week 2 = 20.9 with 95% lower confidence limit of 16.6, p< 0.025 2HFP: Mean Increase over baseline at end of Week 5 = 27.6 with 95% lower confidenc
Slide 41: Primary and Secondary Safety Endpoints Met
Primary and Secondary Safety Endpoints Met Primary Safety Endpoint Met – Decrease in Number of Falls Secondary Safety Endpoint Met - Headache Disability Index Showed a General Lowering Comparison of Falls at Baseline and End of Week 2 Headache Disability Index N=60
Slide 42: Long Term Treatment Study in TBI
Long Term Treatment Study in TBI Durability of the PoNS Treatment Study completed May 28th, 2017 Tactile Communication Neurorehabilitation Laboratory at University of Wisconsin-Madison Sponsored by US Army Double blind randomized controlled trial in people with mild to moderate TBI 22/21 people with
Slide 43: People with TBI's Balance Significantly Better at Weeks 14 and 26
People with TBI’s Balance was Significantly Better at 2 Weeks, 14 Weeks and 26 Weeks Normal Range SOT Score N=221 12 weeks washout – no stimulation SOT score comparison 12 weeks washout – no stimulation On average people with TBI improved from an impaired SOT score to normal SOT score in 14 weeks of
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